Comparative Effects of Pressure and Visual Biofeedback Training on Pain, Disability, Range of Motion Among Patients With Forward Head Posture Correction: A Randomized Controlled Trial

Study Description

This study is a two-arm, parallel-group, randomized controlled trial designed to compare the effects of pressure biofeedback training and visual biofeedback training in patients with forward head posture (FHP). The study will evaluate the effects of both biofeedback modalities on pain intensity, functional disability, cervical range of motion, and postural alignment.

The study will be conducted at Akbar Niazi Teaching Hospital and Al Kauthar International Hospital, Bhara Kahu, Islamabad, after obtaining formal permission from the respective institutions. Participants diagnosed with forward head posture who fulfill the predefined inclusion and exclusion criteria will be recruited for the study. Eligible participants will be informed about the purpose, procedures, potential benefits, and possible risks of the study, and written informed consent will be obtained before enrollment.

A total of 38 participants will be recruited and randomly allocated into two equal groups, with 19 participants in each group. Randomization will be performed using a computer-generated randomization method to minimize selection bias and ensure an approximately equal distribution of participants between the two intervention groups.

Intervention Groups

Group 1 - Pressure Biofeedback Training: Participants allocated to the pressure biofeedback group will receive cervical muscle activation and postural training using a pressure biofeedback cuff. The cuff will be positioned appropriately to provide feedback regarding cervical movement and muscle activation. Participants will be instructed to perform the prescribed exercises while maintaining the desired cervical position and controlling the pressure level according to the study protocol. The pressure biofeedback will provide immediate feedback to assist participants in developing appropriate deep cervical muscle activation and maintaining improved head and neck alignment.

Group 2 - Visual Biofeedback Training: Participants allocated to the visual biofeedback group will receive postural and cervical control training using visual feedback. Visual feedback will be provided through a mirror and/or visual display screen. Participants will be instructed to observe their head and neck position and actively correct forward head posture according to predefined postural landmarks and instructions provided by the therapist. The visual feedback will allow participants to immediately observe and modify their cervical alignment during the prescribed exercises.

Intervention Duration and Frequency

Both groups will receive their respective biofeedback interventions for 6 weeks, with treatment sessions conducted three times per week. The intervention will therefore consist of a structured 6-week training period with comparable treatment frequency between the two groups. Both groups will receive standardized instructions regarding exercise performance, posture correction, and adherence to the intervention protoco Outcome Assessment

Baseline assessment will be performed before commencement of the intervention. The primary and secondary outcome measures will be assessed using standardized and appropriate measurement procedures.

The study outcomes will include:

1. Pain intensity: Pain will be assessed using the Numeric Pain Rating Scale (NPRS).
2. Functional disability: Neck-related functional disability will be assessed using the Neck Disability Index (NDI).
3. Cervical range of motion: Cervical flexion, extension, right rotation, and left rotation will be assessed using goniometry.
4. Postural alignment: Forward head posture will be assessed using the craniovertebral angle (CVA), with a smaller CVA indicating greater forward head positioning.

Outcome measurements will be recorded at baseline, after 3 weeks, and after completion of the 6-week intervention to evaluate changes over time and differences between the two intervention groups.

Randomization and Allocation

After completion of baseline assessment and confirmation of eligibility, participants will be randomly assigned in a 1:1 ratio to either the pressure biofeedback training group or the visual biofeedback training group. A computer-based randomization procedure will be used for group allocation.

Data Management and Statistical Analysis

All collected data will be coded and entered into the statistical software IBM SPSS Statistics, using the latest available version at the time of analysis. Descriptive statistics will be used to summarize participant characteristics and outcome measures. The Shapiro-Wilk test will be used to assess the normality of continuous data.

Depending on the distribution of the data and the assumptions of the statistical tests, appropriate parametric or non-parametric tests will be applied. For repeated measurements within groups, appropriate repeated-measures statistical procedures will be used. Between-group comparisons will be performed to determine whether there are statistically significant differences in changes in pain, disability, cervical range of motion, and postural alignment between the pressure biofeedback and visual biofeedback groups.

Statistical significance will be considered at p < 0.05. Where appropriate, effect sizes and confidence intervals will also be reported to provide an estimate of the magnitude and precision of the treatment effects.

Primary Purpose

The primary purpose of this randomized controlled trial is to determine whether pressure biofeedback training or visual biofeedback training is more effective in improving clinical and postural outcomes in individuals with forward head posture.

The study will specifically compare the effects of the two interventions on pain intensity, neck-related functional disability, cervical range of motion, and craniovertebral angle, thereby determining which biofeedback modality provides greater clinical benefit over the 6-week intervention period.